Reproducibility of Exercise Interventions in Randomized Controlled Trials for the Treatment of Rotator Cuff-Related Shoulder Pain: A Systematic Review.

OBJECTIVE: To determine the reproducibility of exercise therapy interventions in randomized controlled trials for rotator cuff-related shoulder pain (RCRSP). DATA SOURCES: Data sources included Medline, Cumulative Index to Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, and SPORTDiscus from studies published from database inception to April 23, 2022. STUDY SELECTION: Randomized controlled trials studying the use of exercise therapy for RCRSP. DATA EXTRACTION: Two reviewers extracted exercise reporting details from all studies using the Template for Intervention Description and Replication (TIDieR) and the modified Consensus on Exercise Reporting Template (CERT). The same 2 reviewers assessed risk of bias of all studies using Cochrane Risk of Bias Tool version 2.0. DATA SYNTHESIS: For 104 studies meeting inclusion criteria, the average number of items reported on the TIDieR was 5.27 (SD 2.50, range 1-12 out of 12) and 5.09 (SD 4.01, range 0-16 out of 16) on the CERT. Improved reporting over time was seen on both the TIDieR and CERT dating back to 1993 and through April 23, 2022. When comparing groups of studies published before and after the TIDieR (2014) and CERT (2016) were established, a statistically significant increase in median scores was noted on the TIDieR (P=.02) but not the CERT (P=.31). Quality of exercise therapy reporting was highest in studies with "low risk" of bias, and lowest in studies with "high risk" of bias on the RoB-2. CONCLUSION: Overall exercise reporting in trials for RCRSP is incomplete despite the development of the TIDieR and CERT checklists. This has implications for translating evidence into practice.

Trials Investigating Exercise for Low Back Pain Lack Pragmatic Application: A Systematic Review.

OBJECTIVE: To systematically review the orientation of trials analyzing exercise for low back pain (LBP) on the efficacy-effectiveness spectrum. DATA SOURCES: PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Ovid MEDLINE were searched for trials published between January 1, 2010, and August 13, 2022. STUDY SELECTION: Randomized controlled trials investigating exercise for adults with LBP. DATA EXTRACTION: Two reviewers independently used the Rating of Included Trials on the Efficacy-Effectiveness Spectrum (RITES) tool to determine the efficacy-effectiveness orientation. The same 2 reviewers assessed the risk of bias for all studies using the Cochrane Collaboration risk of bias 2.0 tool. DATA SYNTHESIS: The search identified 2975 records. Full-text review was conducted on 674 studies, and 159 studies were included. The proportion of trials with a strong or rather strong efficacy orientation (RITES rating=1 or 2), balanced emphasis (RITES rating=3), or strong or rather strong effectiveness (RITES rating=4 or 5) orientation on the efficacy-effectiveness spectrum within each RITES domain were reported. A greater proportion of trials had an efficacy orientation when compared with effectiveness or a balanced emphasis within 4 domains: participant characteristics: efficacy 43.9%, 41.9% effectiveness, balanced 14.5%; trial setting: 69.0% efficacy, effectiveness 15.8% balanced 15.2%; flexibility of interventions: 74.2% efficacy, effectiveness 8.8%, balanced 17.0%; clinical relevance of experimental and comparison interventions: 50.3% efficacy, 33.3% effectiveness 33.3%, balanced 16.4%. A high risk of bias was found in 42.1% (n=67) of trials. CONCLUSION: Trials investigating the effect of exercise for LBP have a greater orientation toward efficacy across multiple trial design domains. Researchers should consider pragmatic designs in future trials to improve generalizability. Clinicians should consider the efficacy-effectiveness orientation when translating evidence into clinical practice.

Preoperative conservative treatment is insufficiently described in clinical trials of lumbar fusion: a scoping review.

PURPOSE: To identify how pre-surgical conservative care is characterized and reported in randomized controlled trials of adults undergoing elective lumbar fusion, including duration and type of treatment. METHODS: The study design is a scoping review. Data sources include PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Ovid Medline, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL). All randomized controlled trials published in English between January 1, 2005, and February 15, 2022, assessing lumbar fusion as the intervention were included in this review. RESULTS: Of 166 studies, 62.0% reported a failure in conservative care prior to lumbar fusion, but only 15.1% detailed the type of specific conservative care received. None of the trials provided sufficient details to understand the nature of the pre-surgical conservative treatment, such as frequency, recency/timing, or dosage of conservative interventions. CONCLUSION: Although roughly two-thirds of trials reported that patients failed conservative care prior to receiving a lumbar fusion, few studies named the conservative intervention provided and no studies provided any details regarding dosing or recency of care. This lack of information creates ambiguity in the surgical decision-making process, setting the assumption that all patients received adequate conservative care prior to surgery. Details about pre-surgical conservative care should be disclosed to allow for appropriate clinical application, decision-making, and interpretation of treatment effects.

What is the incidence of subsequent adjacent joint injury after patellofemoral pain?

OBJECTIVE: To investigate the incidence of subsequent lumbar spine, hip, and ankle-foot injuries after a diagnosis of patellofemoral pain. DESIGN: Retrospective cohort study. SETTING: Military Health System. PARTICIPANTS: Individuals (n = 92,319) ages 17-60 diagnosed with patellofemoral pain between 2010-2011. INTERVENTIONS: Therapeutic exercise. MAIN OUTCOME MEASURES: Frequency of adjacent joint injuries in the 2-year period after initial patellofemoral pain injury, and hazard ratios (HR) with 95% confidence interval (CI) and Kaplan-Meier survival curves for risk of adjacent joint injury based on receiving therapeutic exercise for the initial injury. RESULTS: After initial patellofemoral pain diagnosis, 42,983 (46.6%) individuals sought care for an adjacent joint injury. Of these, 19,587 (21.2%) were subsequently diagnosed with a lumbar injury, 2837 (3.1%) a hip injury, and 10,166 (11.0%) an ankle-foot injury. One in five (19.5%; n = 17,966) received therapeutic exercise which reduced the risk of having a subsequent lumbar (HR = 0.78, 95% CI 0.76-0.81), hip (HR = 0.93, 95% CI 0.87-0.98) or ankle-foot (HR = 0.86, 95% CI 0.83-0.90) injury. CONCLUSION: The results suggest that a high number of individuals with patellofemoral pain will sustain an adjacent joint injury within 2 years although causal relationships cannot be determined. Receiving therapeutic exercise for the initial knee injury reduced the risk of sustaining an adjacent joint injury. This study helps provide normative data for subsequent injury rates in this population and guide development of future studies designed to understand causal factors.

Timing of physical therapy for individuals with patellofemoral pain and the influence on healthcare use, costs and recurrence rates: an observational study.

BACKGROUND: Early physical therapy has been shown to decrease downstream healthcare use, costs and recurrence rates in some musculoskeletal conditions, but it has not been investigated in individuals with patellofemoral pain. The purpose was to evaluate how the use and timing of physical therapy influenced downstream healthcare use, costs, and recurrence rates. METHODS: Seventy-four thousand four hundred eight individuals aged 18 to 50 diagnosed with patellofemoral pain between 2010 and 2011 in the Military Health System were categorized based on use and timing of physical therapy (first, early, or delayed). Healthcare use, costs, and recurrence rates were compared between the groups using descriptive statistics and a binary logit regression. RESULTS: The odds for receiving downstream healthcare use (i.e. imaging, prescription medications, and injections) were lowest in those who saw a physical therapist as the initial contact provider (physical therapy first), and highest in those who had delayed physical therapy (31-90 days after patellofemoral pain diagnosis). Knee-related costs for those receiving physical therapy were lowest in the physical therapy first group ($1,136, 95% CI $1,056, $1,217) and highest in the delayed physical therapy group ($2,283, 95% CI $2,192, $2,374). Recurrence rates were lowest in the physical therapy first group (AOR = 0.55, 95% CI 0.37, 0.79) and highest in the delayed physical therapy group (AOR = 1.78, 95% CI 1.36, 2.33). CONCLUSIONS: For individuals with patellofemoral pain using physical therapy, timing is likely to influence outcomes. Healthcare use and costs and the odds of having a recurrence of knee pain were lower for patients who had physical therapy first or early compared to having delayed physical therapy.

Evidence for the Effectiveness of Feedback from Wearable Inertial Sensors during Work-Related Activities: A Scoping Review.

Background: Wearable inertial sensor technology (WIST) systems provide feedback, aiming to modify aberrant postures and movements. The literature on the effects of feedback from WIST during work or work-related activities has not been previously summarised. This review examines the effectiveness of feedback on upper body kinematics during work or work-related activities, along with the wearability and a quantification of the kinematics of the related device. Methods: The Cinahl, Cochrane, Embase, Medline, Scopus, Sportdiscus and Google Scholar databases were searched, including reports from January 2005 to July 2021. The included studies were summarised descriptively and the evidence was assessed. Results: Fourteen included studies demonstrated a 'limited' level of evidence supporting posture and/or movement behaviour improvements using WIST feedback, with no improvements in pain. One study assessed wearability and another two investigated comfort. Studies used tri-axial accelerometers or IMU integration (n = 5 studies). Visual and/or vibrotactile feedback was mostly used. Most studies had a risk of bias, lacked detail for methodological reproducibility and displayed inconsistent reporting of sensor technology, with validation provided only in one study. Thus, we have proposed a minimum 'Technology and Design Checklist' for reporting. Conclusions: Our findings suggest that WIST may improve posture, though not pain; however, the quality of the studies limits the strength of this conclusion. Wearability evaluations are needed for the translation of WIST outcomes. Minimum reporting standards for WIST should be followed to ensure methodological reproducibility.

Leveraging healthcare utilization to explore outcomes from musculoskeletal disorders: methodology for defining relevant variables from a health services data repository.

BACKGROUND: Large healthcare databases, with their ability to collect many variables from daily medical practice, greatly enable health services research. These longitudinal databases provide large cohorts and longitudinal time frames, allowing for highly pragmatic assessment of healthcare delivery. The purpose of this paper is to discuss the methodology related to the use of the United States Military Health System Data Repository (MDR) for longitudinal assessment of musculoskeletal clinical outcomes, as well as address challenges of using this data for outcomes research. METHODS: The Military Health System manages care for approximately 10 million beneficiaries worldwide. Multiple data sources pour into the MDR from multiple levels of care (inpatient, outpatient, military or civilian facility, combat theater, etc.) at the individual patient level. To provide meaningful and descriptive coding for longitudinal analysis, specific coding for timing and type of care, procedures, medications, and provider type must be performed. Assumptions often made in clinical trials do not apply to these cohorts, requiring additional steps in data preparation to reduce risk of bias. The MDR has a robust system in place to validate the quality and accuracy of its data, reducing risk of analytic error. Details for making this data suitable for analysis of longitudinal orthopaedic outcomes are provided. RESULTS: Although some limitations exist, proper preparation and understanding of the data can limit bias, and allow for robust and meaningful analyses. There is the potential for strong precision, as well as the ability to collect a wide range of variables in very large groups of patients otherwise not captured in traditional clinical trials. This approach contributes to the improved understanding of the accessibility, quality, and cost of care for those with orthopaedic conditions. CONCLUSION: The MDR provides a robust pool of longitudinal healthcare data at the person-level. The benefits of using the MDR database appear to outweigh the limitations.

Thoracic manipulation versus mobilization in patients with mechanical neck pain: a systematic review.

OBJECTIVES: Thoracic manipulation is widely used in physical therapy and has been shown to be effective at addressing mechanical neck pain. However, thoracic mobilization may produce similar effects. The purpose of this systematic review was to evaluate the current literature regarding the effectiveness of thoracic manipulation versus mobilization in patients with mechanical neck pain. METHODS: ProQuest, NCBI-PubMed, APTA's Hooked on Evidence, Cochrane Library, CINAHL and SPORTDiscus were searched to identify relevant studies. Fourteen studies meeting the inclusion criteria were analyzed using the Physiotherapy Evidence Database (PEDro) scale and the GRADE approach. RESULTS: The literature as assessed by the PEDro scale was fair and the GRADE method showed overall quality ranging from very low to moderate quality. The 14 included studies showed positive outcomes on cervical pain levels, range of motion, and/or disability with the use of thoracic manipulation or mobilization. There was a paucity of literature directly comparing thoracic manipulation and mobilization. DISCUSSION: Current limitations in the body of research, specifically regarding the use of thoracic mobilization, limit the recommendation of its use compared to thoracic manipulation for patients with mechanical neck pain. There is, however, a significant amount of evidence, although of varied quality, for the short-term benefits of thoracic manipulation in treating patients with this condition. Further high quality research is necessary to determine which technique is more effective in treating patients with mechanical neck pain.

Evaluation of Transparency and Openness Guidelines in Physical Therapist Journals.

OBJECTIVE: The goals of this study were to evaluate the extent that physical therapist journals support open science research practices by adhering to the Transparency and Openness Promotion (TOP) guidelines and to assess the relationship between journal scores and their respective journal impact factor (JIF). METHODS: Scimago, mapping studies, the National Library of Medicine, and journal author guidelines were searched to identify physical therapist journals for inclusion. Journals were graded on 10 standards (29 available total points) related to transparency with data, code, research materials, study design and analysis, preregistration of studies and statistical analyses, replication, and open science badges. The relationship between journal transparency and openness scores and their JIF was determined. RESULTS: Thirty-five journals' author guidelines were assigned transparency and openness factor scores. The median score (interquartile range) across journals was 3.00 out of 29 (3.00) points (for all journals the scores ranged from 0 to 8). The 2 standards with the highest degree of implementation were design and analysis transparency (reporting guidelines) and study preregistration. No journals reported on code transparency, materials transparency, replication, and open science badges. TOP factor scores were a significant predictor of JIF scores. CONCLUSION: There is low implementation of the TOP standards by physical therapist journals. TOP factor scores demonstrated predictive abilities for JIF scores. Policies from journals must improve to make open science practices the standard in research. Journals are in an influential position to guide practices that can improve the rigor of publication which, ultimately, enhances the evidence-based information used by physical therapists. IMPACT: Transparent, open, and reproducible research will move the profession forward by improving the quality of research and increasing the confidence in results for implementation in clinical care.

Do Maladaptive Imaging Beliefs Predict Self-Reported Pain Interference and Physical Function in Patients With Musculoskeletal Disorders?

OBJECTIVE: To determine if maladaptive imaging beliefs correlated with, and predicted pain interference and physical function outcomes in people with musculoskeletal pain disorders. DESIGN: A prospective cohort study of patients with musculoskeletal disorders receiving outpatient physical therapy from April 2022 to August 2023. METHODS: Four questions about imaging were asked to assess maladaptive beliefs, the need to rule out serious conditions, guide treatment, determine diagnosis, and validate symptoms. Correlations with beliefs and outcomes were assessed using Kendall's tau rank and Spearman's rho correlation coefficients. Generalized linear models determined if these beliefs predicted outcomes at baseline and 6 weeks. RESULTS: The cohort included 152 participants (mean [standard deviation] age: 56.13 [15.13]; 32.2% male). Maladaptive imaging beliefs correlated positively with pain interference and negatively with physical function. The need to rule out serious conditions and validate symptoms correlated with pain interference (range: τb = 0.17, 0.20; P = .003, .0121) and physical function (range: ρ = -0.22, -0.22; P = .006, .008). All but 1 belief correlated with pain interference (range: τb = 0.19, 0.24; P<.001, .004) and physical function (range: ρ = -0.26, -0.21; P = .001, .009) at 6 weeks. Each additional belief slightly increased pain interference at 6 weeks (ß = 0.01; 95% CI: 0.001, 0.03; P = .04) and lowered physical function at both baseline (ß = -0.97; 95% CI: -1.66, -0.28; P = .01) and 6 weeks (ß = -0.76; 95% CI: -1.37, -0.15; P = .02). CONCLUSION: Maladaptive imaging beliefs were significantly (albeit weakly) correlated with pain and physical function. Each additional maladaptive imaging belief increased pain interference at 6 weeks and lowered physical function at baseline and 6 weeks. Beliefs about the necessity of imaging to properly manage musculoskeletal disorders may influence outcomes. J Orthop Sports Phys Ther 2024;54(9):1-10. Epub 5 July 2024. doi:10.2519/jospt.2024.12625.

Evaluating and Characterizing the Scope of Care for Interventions Labeled as Manual Therapy in Low Back Pain Trials: A Scoping Review.

OBJECTIVE: The purpose of this scoping review was to evaluate and characterize the scope of care for low back pain that falls under the specific label of manual therapy. METHODS: PubMed database, Ovid MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Central Register of Controlled Trials (CENTRAL), and SPORTDiscus were searched from journal inception through May 2022 for randomized controlled trials that investigated the treatment of low back pain using manual therapy. Terminology used to define manual therapy was extracted and categorized by using only the words included in the description of the intervention. An expert consultation phase was undertaken to gather feedback. RESULTS: One hundred seventy-six trials met final inclusion criteria, and 169 unique terms labeled as manual therapy for the treatment of low back pain were found. The most frequent terms were mobilization (29.0%), manipulation (16.0%), and thrust (6.4%). Eight percent of trials did not define or specify what type of manual therapy was used in the study. After removing duplicates, 169 unique terms emerged within 18 categories. CONCLUSIONS: Manual therapy intervention labels used in low back pain trials are highly variable. With such variation, the heterogeneity of the intervention in trials is likely large, and the likelihood that different trials are comparing the same interventions is low. Researchers should consider being more judicious with the use of the term manual therapy and provide greater detail in titles, methods, and supplementary appendices in order to improve clarity, clinical applicability, and usefulness of future research. IMPACT: The ability to interpret and apply findings from manual therapy-related research for low back pain is challenging due to the heterogeneity of interventions under this umbrella term. A clear use of terminology and description of interventions by researchers will allow for improved understanding for the role of manual therapy in managing back pain.

Assessing the transparency in reporting of clinical trials investigating manual therapy interventions for low back pain: A methodological review.

RATIONALE: Low back pain (LBP) is a common condition with a significant societal burden. Manual therapy is an effective treatment for LBP and recommended in clinical practice guidelines. While the quantity of literature supporting the use of manual therapy is large, the methodological quality and transparency of this collective work are unclear. AIMS AND OBJECTIVES: Explore the transparency in reporting of clinical trials assessing manual therapy interventions in patients with LBP by comparing planned components in the trial registration with what was reported in the published manuscript. METHODS: Three databases were searched to identify trials assessing the treatment effect of manual therapy for LBP from January 2005 to May 2023. Studies were included if the manual therapy consisted of thrust manipulations, mobilizations or muscle energy techniques. RESULTS: From 4462 studies initially identified, 167 studies remained in the final review after title, abstract and full-text review. Only 87 (52.1%) of the 167 studies were registered (n = 57 prospectively and n = 30 retrospectively). Primary outcomes in the publications were identical to the registration in 54 (62.1%) of the registered trials. Secondary outcomes in the publication were identical to the registration in 27 (31.0%) of the registered trials. The CONSORT reporting guideline was referenced in only 19 (21.8%) trials. Multiple discrepancies between registration and publication were noted for primary and secondary outcomes. All trials had eligibility criteria in the registration that matched their corresponding manuscript, while only four (4.6%) trial registrations addressed any type of statistical analysis plan. CONCLUSION: Approximately half of the trials were not registered. Of those registered, only half were registered prospectively. Substantial discrepancies existed between registered and published outcomes that were never addressed by the authors, raising questions about potential bias. Transparency can be improved through more stringent requirements during manuscript submission to journals, and better reporting of the rationale for discrepancies between registration and publication.

Adverse Events Reported in Trials Assessing Manual Therapy to the Extremities: A Systematic Review.

Objective: This review aimed to describe the quality and comprehensiveness of adverse event (AE) reporting in clinical trials incorporating manual therapy (MT) as an intervention for extremity conditions using the Consolidated Standards of Reporting Trials (CONSORT)-Harms extension as the benchmark. The secondary aim was to determine whether the quality of AE reporting improved after the availability of the CONSORT reporting checklist. Design: Systematic review. Methods: A literature search was conducted using multiple databases to identify trials where MT was used to treat extremity conditions. Studies that reported AEs were identified and evaluated using the CONSORT-Harms extension. The frequency of trials reporting study AEs before and after the publication of the updated 2010 CONSORT statement was calculated, along with the categorization of how study AEs were reported. Results: Of the 55,539 studies initially identified, 220 trials met all inclusion criteria. Eighty trials (36.4%) reported AE occurrence. None of the studies that reported AEs adhered to all 10 criteria proposed by the 2010 CONSORT-Harms extension. The most commonly reported criterion was number four, which clarified how AE-related information was collected (30% of trials). The least reported criterion was number six, which describes the participant withdrawals for each arm due to AEs and the experience with the allocated treatment (1.3% of trials). The nomenclature used to describe AEs varied substantially. Fifty-nine of 76 trials (33.3%) were published after the updated CONSORT Harms-checklist was available, compared to 21 of 44 trials (46.7%) published before it was available. Conclusion: Reporting of AEs in trials investigating MT for extremity conditions is poor. Every included trial lacked adherence to all 10 criteria proposed by the CONSORT-Harms Extension. The quality and comprehensiveness of AE reporting did not improve after the most recent CONSORT update recommending AE reporting. Clinicians must obtain informed consent before performing any intervention, including MT, which requires disclosing potential risks, which could be better known with improved tracking, analyzing, and reporting of AEs. The authors recommend improved adherence to best practices for adequately tracking and reporting AEs in future MT trials.

What are patients' perspectives on the value of physical therapy? A prospective cohort study.

PURPOSE: To assess and identify patients' perceptions about the overall value of physical therapy services for musculoskeletal conditions and how these values were associated with their outcomes. METHODS: The association between the perceived value of physical therapy (as a score) and Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference and physical function at 6-weeks was assessed in a prospective cohort. Generalised linear models were used to identify relationships between the value of physical therapy score and PROMIS outcomes. Kendall's tau was used to identify correlations between responses and outcomes. RESULTS: A total of 133 participants met the final inclusion criteria. The majority of participants were female (63.9%) with a mean age of 55.53 (SD 15.36) years. A majority of participants (63.9%) reported a previous positive personal experience with physical therapy. There was no significant relationship between perceived value of physical therapy and pain interference (ß -0.32, p = 0.07, 95% CI-0.67, 0.03) or physical function (ß 0.19, p = 0.29, 95% CI-0.16, 0.54). Stronger beliefs in agreement with the value of non-invasive treatment were significant, but weakly correlated with lower pain interference (r = -0.18, p = 0.048) and higher physical function scores (r = 0.22, p = 0.03). CONCLUSIONS: Participants had an overall positive perception of the value of physical therapy prior to initiating physical therapy, but this perception was not associated with 6-week pain and function outcomes. A better understanding of the driving factors encouraging patients to seek physical therapy services is needed to provide value-based care.

The influence of exercise therapy dosing on pain and functional outcomes in patients with subacromial pain syndrome: A systematic review.

Background: The objective was to identify exercise therapy dosing parameters for subacromial pain syndrome (SAPS) associated with improved pain and function outcomes (via effect sizes) and determine the extent of exercise intervention reproducibility. Methods: An electronic search of PubMed/MEDLINE, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Cochrane Database of Systematic Reviews, and SportDiscus identified studies that used exercise therapy exclusively to treat SAPS. Exercise therapy dosing parameters were extracted and within-group effect sizes were calculated for all pain and functional outcomes. Template for Intervention Description and Replication and Consensus on Exercise Reporting were used to record intervention reporting. The risk of bias and Grading of Recommendations, Assessment, Development, and Evaluation were assessed by two reviewers. Results: Twenty-one trials with 674 subjects were included. Effect sizes for pain and function were large in 18 studies, medium in six studies, and small or no effect in four studies, despite the type of supervision. With moderate certainty, effect sizes of pain and function were not influenced by exercise therapy dosing parameters. Intervention reporting was generally poor. Discussion: Exercise therapy for SAPS was associated with large effect sizes for improvement in pain and function but optimal exercise therapy dosing parameters could not be identified. Strong recommendations conditionally suggest treating SAPS with a variety of exercise therapy dosing parameters.

The majority of clinical trials assessing mobilization and manipulation for neck pain lack a pragmatic approach: a systematic review of 174 trials.

BACKGROUND: Disorders of the cervical spine are some of the costliest musculoskeletal conditions to manage globally. Joint mobilization and manipulation have been shown to be an effective treatment for neck pain. However, the generalizability and clinical translation depends on the nature of the trial designs that inform its use. The extent to which randomized control trials (RCTs) assessing manual therapy treatments for cervical spine disorders fall on the efficacy (explanatory) -effectiveness (pragmatic) spectrum often informs how the findings are translated into clinical practice. OBJECTIVE: The aim of this systematic review was to determine where RCTs of manual therapy for neck disorders fall on the efficacy-effectiveness spectrum. METHODS: A search of three electronic databases including PubMed, CINAHL, and CENTRAL were completed for trials published from inception to May 2023. RCTs in which joint mobilization or manipulation were used to treat cervical spine disorders were assessed on the effectiveness-efficacy spectrum using the Rating of Included Trials on the Efficacy-Effectiveness Spectrum (RITES) tool and risk of bias using the Revised Cochrane Risk of Bias tool. RESULTS: A total of 174 trials met eligibility. RITES domain two trial setting (71.3% vs 16.1%), domain three flexibility of intervention(s) (62.1% vs 23%), and domain four clinical relevance of experimental and comparison intervention(s) (51.7% vs 29.3%) all favored efficacy over effectiveness. Domain one participant characteristic(s) had a slightly greater emphasis on effectiveness compared to efficacy (36.8% vs 44.8%). Most studies (96%) had at least some risk of bias. CONCLUSION: Over half of the RCTs assessing the treatment effect of joint mobilization and manipulation for neck pain favor efficacy (explanatory) over effectiveness (pragmatic) designs. Future RCTs on this topic should consider a greater emphasis on pragmatic trial design components in order to better reflect real-world translation to clinical practice.

Trials and tribulations of transparency related to inconsistencies between plan and conduct in peer-reviewed physiotherapy publications: A methodology review.

RATIONALE: The physiotherapy profession strives to be a leader in providing quality care and strongly recognizes the value of research to guide clinical practice. Adherence to guidelines for research reporting and conduct is a significant step towards high-quality, transparent and reproducible research. AIM/OBJECTIVE: Assess integrity between planned and conducted methodology in randomized controlled trials (RCTs) and systematic reviews (SRs) published in physiotherapy journals. METHODS: Eighteen journals were manually searched for RCTs and SRs published from 1 July 2021 through 31 December 2021. Studies were included if the journal or specific study was indexed in PubMed and published/translated in English. Descriptive statistics determined congruence between preregistration data and publication. RESULTS: Forty RCTs and 68 SRs were assessed. Forty-three SRs included meta-analysis (MA). Of the 34 registered RCTs, 7 (20.6%) had no discrepancy between the registration and publication. Two trials (5.9%) addressed all discrepancies, 4 (11.8%) addressed some and 21 (61.8%) did not address any discrepancies. Of the 36 registered MAs, 33 (91.7%) had discrepancies between the registration and publication. Two (5.6%) addressed all discrepancies and three (8.3%) had no discrepancies. Eight SRs without MA published information not matching their registration, and none provided justification for the discrepancies. CONCLUSION: Most RCTs/SRs were registered; the majority had discrepancies between preregistration and publication, potentially influencing the outcomes and interpretations of findings. Journals should require preregistration and compare the submission with the registration information when assessing publication suitability. Readers should be aware of these inconsistencies and their implications when interpreting and translating results into practice.

How Reproducible Are Manual Therapy Interventions in Trials for Low Back Pain? A Scoping Review.

OBJECTIVES: To assess the reproducibility of manual therapy interventions used in clinical trials for low back pain (LBP), and summarize knowledge gaps in assessing the reproducibility of manual therapy interventions for LBP. DESIGN: Scoping review. LITERATURE SEARCH: PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Central Register of Controlled Trials (CENTRAL), and Embase were searched for trials from inception through April 2023. STUDY SELECTION CRITERIA: Randomized controlled trials were included if they described the use of manual therapy to treat LBP in adults 18 to 65 years old and were accessible in English. DATA SYNTHESIS: The Consensus on Exercise Reporting Template (CERT) checklist, used for exercise reporting, was previously modified for manual therapy reporting. This 11-item modified CERT was used to extract details of manual therapy reporting in the included trials. Frequency counts were calculated to identify items most and least commonly reported. RESULTS: Of 128 trials, none reported all 11 items of the modified CERT. The most commonly reported items were the description of how the application of manual therapy was decided (n = 113, 88.3%) and a description of adjunct interventions provided (n = 82, 64.1%). The least reported items were the description of an associated home program (n = 27, 21.1%) and a detailed description of the application of manual therapy (n = 22, 17.2%). CONCLUSION: Reporting of manual therapy interventions in trials investigating LBP was poor overall, limiting the reproducibility of these treatments. Using a checklist designed explicitly for manual therapy intervention reporting may improve reproducibility of these interventions and help align clinical outcomes with experimental findings. J Orthop Sports Phys Ther 2024;54(4):1-10. Epub 29 January 2024. doi:10.2519/jospt.2024.12201.

Self-acknowledged limitations in exercise therapy trials for low back pain.

RATIONALE: Despite the widespread recommendation to engage in therapeutic exercise for the treatment of low back pain (LBP), there is conflicting evidence regarding clinical outcomes and effectiveness. Poor methodological quality may be to blame for reducing the overall strength of evidence for this intervention, yet little is known about the difficulties researchers encounter when designing and implementing their study methods. AIMS AND OBJECTIVES: The aim of this study was to characterize the extent and type of self-acknowledged limitations (SALs) in exercise therapy trials for LBP to gain a better understanding of challenges encountered when conducting this research. METHODS: This is a methodological review of clinical trials in which SALs were extracted, categorized by theme and subcategorized within each theme. Counts and prevalence rates were tabulated for the number of SALs in each category and subcategory. RESULTS: There were 914 SALs among the 312 included trials, with a mean of 2.93 (95% confidence interval [CI], 2.77-3.09) per trial. Analysis of the data resulted in the development of 13 distinct categories of limitations, among which were 37 subcategories. The top three categories pertained to statistical power (14.3% of total SALs), study length and/or follow-up (14.3%) and inclusion criteria (14.2%). The top three subcategories were lack of long-term follow-up (13.8% of total SALs), inadequate sample size (13.3%) and inclusion of specific populations (12.3%). CONCLUSION: Statistical power, study length and/or follow-up, and inclusion criteria were the three most commonly reported categories of SALs in exercise trials for LBP. Lack of long-term follow-up, inadequate sample size and inclusion of specific populations were the most common subcategories. Research protocols recognizing and avoiding these limitations will enhance the overall quality of evidence of exercise therapy trials for LBP.

Associations between smoking history, baseline pain interference and symptom distribution, and physical function at discharge, in individuals seeking care for musculoskeletal pain.

OBJECTIVE: Study of the association between smoking and pain intensity has produced conflicting results; with less focus on pain interference. Different pain constructs could have varying associations with smoking behaviors. This study sought to investigate the association between smoking history and not only pain intensity, but also pain interference, symptom distribution and physical function. METHODS: Smoking history (current, past, or none), pain interference (Pain, Enjoyment of Life, and General Activity scale), symptom distribution and physical function scores were extracted from medical records of patients seen in physical therapy for common sites of musculoskeletal pain (lumbar and cervical spine, knee, or hip). Generalized linear models assessed the relationship between smoking history and pain/function. RESULTS: 833 patients from an integrated healthcare system were included (mean: 57.6 years, SD=16.3; 43 % male). After controlling for several variables, current smokers had significantly higher baseline pain interference scores compared to never and former smokers (beta [B]: 0.65, 95 %CI: 0.13 to 1.18, P=.02). Smoking was not a significant predictor of symptom distribution at baseline [B: 0.17, 95 %CI -0.06 to 0.42, P=.16] or physical function scores at discharge [B: -0.03, 95 %CI: -0.08 to 0.02, P=.25]. CONCLUSION: Smokers experienced a greater impact of pain at baseline. However, symptom distribution at intake and function upon discharge were similar between all smoking groups. These findings suggest smoking cessation and abstinence may be important recommendations to help curb pain interference.